Textbook of Pharmacoepidemiology is a modified, shortened version of the fourth edition of Strom's Pharmacoepidemiology, which was first published in 1989. This textbook is divided into 4 sections: introduction to the discipline, data sources, major methodological issues, and applications of pharmacoepidemiology. This textbook provides a well-resourced “tool kit” for those being trained in pharmacoepidemiology.
Chapters 1 through 6 arrange the foundations for the discipline. Chapter 1 discusses the definition and historical background of pharmacoepidemiology. The current drug approval process in the United States is also discussed. As noted by the authors, “pharmacoepidemiology applies the methods of epidemiology to the content area of clinical pharmacology,” therefore, chapters 2 through 4 are devoted to the principles of epidemiology and clinical pharmacology relevant to pharmacoepidemiology studies. As study designs and sample size determinations are fundamental issues that need to be addressed in any study, the discussions on these 2 topics are also useful for students in other health-related areas. Chapters 5 and 6 examine the value of pharmacoepidemiology from academia, industry, and regulatory perspectives.
Chapters 7 through 15 are concerned with different data sources for pharmacoepidemiology studies in the US and around the world. In Chapters 7 through 10, various drug monitoring systems are examined, including the spontaneous Adverse Events Reporting System and the Case-Control Surveillance sponsored by the US FDA, the WTO's international drug monitoring program, and the Prescription-Event Monitoring system in the UK. Strengths, limitations, and applications of these surveillance systems are also examined. Chapters 11 through 13 offer detailed descriptions of databases available for pharmacoepidemiologic studies and Chapter 14 compares the characteristics of these data sources. Over the past 2 decades, the conducting of pharmacoepidemiology research has shifted from using data collected from individual patients to using administrative data or electronic medical records. Administrative data and electronic medical records are designed for purposes other than pharmacoepidemiologic research therefore the quality of such data need to be verified. Hence, in Chapter 15, the validity of raw data is discussed and solutions to measurement errors and incomplete data are recommended. This section serves as a roadmap for beginners in the field who are unfamiliar with the structures of these data.
Chapters 16 through 26 deal with the main methodological issues raised by the various forms of pharmacoepidemiology studies. Specifically, Chapter 16 and 17 cover 3 key issues in pharmacoepidemiology: bias, confounding, and assessment of causality. Chapter 18 discusses the emergence of the concept of molecular pharmacoepidemiology, “the study of the manner that molecular biomarkers alter the clinical effects of medications in populations,” and Chapter 19 is concerned with the potential ethical issues in pharmacoepidemiologic studies. With the advent of new information technology and biological technology, the potential to misuse patient information has also increased. Special attention needs to be given to protect human subjects in pharmacoepidemiologic studies. Chapters 20 and 24 focus on the use of randomized clinical trials and meta-analysis in pharmacoepidemiology, while a discussion of the use of pharmacoepidemiology to study beneficial drug effects is offered in Chapter 21. Because both pharmacoepidemiology and pharmacoeconomics focus on the evaluation of pharmaceuticals, and patients' health-related quality of life is one of the patient-reported outcomes of pharmaceutical therapy, the involvement of pharmacoeconomics and quality of life research in pharmacoepidemiology is discussed in Chapters 22 and 23, respectively. Chapter 25 emphasizes one of the most significant problems in ambulatory pharmacotherapy, ie, patient non-adherence with prescribed medications. The last chapter of the methodology session covers the latest advances in study design and statistical analysis. The content of this chapter is moderately advanced for undergraduate or pharmacy students.
The last section of this textbook focuses on the importance of the role that pharmacoepidemiology plays in contemporary society. Chapter 27 discusses the various applications of pharmacoepidemiology, such as drug utilization review and pharmacoepidemiologic studies of vaccine safety. Chapter 28 concludes the book with some thoughts on the future of pharmacoepidemiology from the perspective of academia, industry, and government, which echoes the discussions in the beginning section of this book.
In general, this textbook is well-written and very informative. From my own personal view, I found the Case Examples feature especially useful. These Case Examples take the reader past simply understanding the concepts and methodological issues in pharmacoepidemiology, preparing them for some hands-on experience in undertaking pharmacoepidemiologic studies in the future. However, this book is not a comprehensive methodological “cookbook” for those who wish to conduct pharmacoepidemiologic studies on their own, nor do the authors claim so. Rather, it is a valuable educational resource for those who wish to learn pharmacoepidemiology. To better fulfill the educational needs of students and facilitate self-learning, the addition of a learning objectives statement at the beginning of each chapter would be valuable. I would definitely recommend this book to students with limited experience with epidemiologic research, such as upper-level undergraduate students, pharmacy students, and entry-level graduate students who wish to learn pharmacoepidemiology. It could also serve as an excellent textbook for an introductory pharmacoepidemiology course.